MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-06-20 for AMC 0493072 manufactured by Gelm Sciences.
[15742882]
Facility alleged leaking during treatment. Rn reports problem with overflow to transducer causing tmp alarm and clotted line. Ebl 30-50a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00525 |
| MDR Report Key | 23210 |
| Date Received | 1995-06-20 |
| Date of Report | 1995-05-15 |
| Date of Event | 1995-04-15 |
| Date Facility Aware | 1995-05-15 |
| Report Date | 1995-05-15 |
| Date Reported to Mfgr | 1995-05-15 |
| Date Added to Maude | 1995-07-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMC |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1995-06-20 |
| Catalog Number | 0493072 |
| Lot Number | UNKNOWN |
| Operator | NO INFORMATION |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23480 |
| Manufacturer | GELM SCIENCES |
| Manufacturer Address | 600 S WAGEN RD ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-06-20 |